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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc. Identifier:
First received: February 21, 2011
Last updated: August 17, 2015
Last verified: September 2012
This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine, or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Sapacitabine and decitabine
Drug: Decitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete remission with duration [ Time Frame: Up to 43 months ] [ Designated as safety issue: Yes ]
  • Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Partial remission with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Hematological improvement with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Stable disease with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Number of units of blood product transfused [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
  • Hospitalized days [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • 1-year survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 485
Study Start Date: January 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Sapacitabine and decitabine
Drug: Sapacitabine and decitabine
Sapacitabine administered in alternating cycles with decitabine
Active Comparator: Arm C
Drug: Decitabine
Decitabine alone

Detailed Description:
This is a multicenter, randomized, Phase 3 study comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newly diagnosed AML based on WHO classification
  • Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
  • ECOG performance status 0-2
  • Adequate renal function
  • Adequate liver function
  • Able to swallow capsules
  • Agree to practice effective contraception
  • Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

  • AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
  • Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine
  • Known to be HIV-positive
  Contacts and Locations
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Please refer to this study by its identifier: NCT01303796

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United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Scripps Cancer Center
La Jolla, California, United States, 92037
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
United States, Florida
Shands Cancer Hospital at University of Florida
Gainesville, Florida, United States, 32608
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
St. Louis University Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
John Theurer Cancer Center at the Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Westchester Hematology Oncology Group, PC
Hawthorne, New York, United States, 10532
Beth Israel Medical Center
New York, New York, United States, 10003
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
MD Anderson Cancer Center
Houston, Texas, United States, 77030-3387
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Medizinische Universitaetsklinik
Innsbruck, Austria
Elisabethinen Krankenhaus
Linz, Austria
Krankenhaus der Barmherzigen Schwestern
Linz, Austria
Univ. Klinik fur Innere Medizin III LKH
Salzburg, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
AKH Wien
Wien, Austria
Hanusch Krankenhaus
Wien, Austria
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerpen, Belgium
AZ Sint-Jan Brugge-Oostende
Brugge, Belgium
Universite Catholique de Louvain
Brussels, Belgium
Centre Hospitalier De Jolimont-Lobbes
La Louviere, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium
CHU d'Amiens Hopital Sud
Amiens, France
Centre Hospitalier de la Cote Basque
Bayonne, France
CHU de Lyon - Hopital Edouard Herriot
Lyon, France
Institut Paoli Calmettes
Marseille, France
CHRU De Montpellier Hopital St. Eloi
Montpellier, France
Centre Hospitalier De Mulhouse
Mulhouse, France
Hopital St Louis Universite Paris 7
Paris, France
Centre Hospitalier de Perigueux
Perigueux, France
Centre Hospitalier d'Annecy
Pringy, France
Centre Hospitalier de Saint-Brieuc Yves Ie Foll
St Brieuc, France
Strasbourg Oncologie Liberale
Strasbourg, France
CHU de Strasbourg - Hopital Civil
Strasbourg, France
CHU de Tours Hopital Bretonneau
Tours, France
Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin
Berlin, Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden
Dresden, Germany
St. Johannes Hospital
Duisburg, Germany
Klinikum Frankfurt Hoechst
Frankfurt, Germany
Asklepios Klinik Altona
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
SLK Kliniken Heilbronn
Heilbronn, Germany
Klinikum St. Georg
Leipzig, Germany
Johannes Wesling Klinikum
Minden, Germany
TU Muenchen
Muenchen, Germany
Universitaetsklinikum Muenster
Muenster, Germany
University of Debrecen
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
Gyor, Hungary
Kaposi Mor Oktato Korhaz
Kaposvar, Hungary
AOU Ospedali Riuniti Umberto I
Ancona, Italy
AO Ospedali Riuniti di Bergamo
Bergamo, Italy
Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli
Bologna, Italy
AO Spedali Civili di Brescia
Brescia, Italy
Universita Cattolica del Sacro Cuore
Campobasso, Italy
AOU Careggi
Firenze, Italy
AOU San Martino IST
Genova, Italy
PO Vito Fazzi
Lecce, Italy
Ospedale San Raffaele
Milano, Italy
AORN Antonio Cardarelli
Napoli, Italy
Uni. Napoli Ospedale Federico lI
Napoli, Italy
AOU Maggiore della Carità di Novara
Novara, Italy
AOOR Villa Sofia Cervello di Palermo
Palermo, Italy
Policlinico San Matteo Di Pavia
Pavia, Italy
AOU San Luigi Gonzaga
Torino, Italy
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku
Gdansk, Poland
Wojewodzki Szpital Specjalistyczny
Legnica, Poland
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica, Poland
University of Lodz N. Copernicus Memorial Hospital
Lodz, Poland
IHT Instytut Hematologii I Transfuzjologii w Warszawie
Warsaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu
Wroclaw, Poland
Hospital Universitari Germans Trias i Pujol ICO Badalona
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital De La Santa Creu Sant Pau
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Canarias
La Laguna, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Clinico Universitario
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Hospital Universitari "La Fe"
Valencia, Spain
Sunderby Hospital
Lulea, Sweden
Skåne Universitetssjukhus Univ Hospital Lund
Lund, Sweden
Inselspital Bern
Bern, Switzerland
United Kingdom
Kings College Hospital and Guys and St Thomas' Hospital
London, United Kingdom
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Study Chair: Hagop Kantarjian, M.D. M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Cyclacel Pharmaceuticals, Inc. Identifier: NCT01303796     History of Changes
Other Study ID Numbers: CYC682-12
Study First Received: February 21, 2011
Last Updated: August 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cyclacel Pharmaceuticals, Inc.:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015